CG FUTURE® 638RL30 (UDI 00613994758651)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00613994758651), received between Mar 14, 2017 and Jan 10, 2023 — classified as 33 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 9 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND R EPLACED WITH A 31MM ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16132708 ↗
• InjuryMar 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13830742 ↗
• MalfunctionFeb 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MEDTRONIC RECEIVED INFORMATION THAT THIS 30MM MITRAL ANNULOPLASTY RING WAS IMPLANTED 2 MONTHS AND 5 DAYS BEYOND ITS USE-BY DATE. IT WAS REPORTED THAT THE "SURGERY STAFF MISTOOK THE EXPIRATION DATE OF THE DEVICE BEFORE OPENING THE PACKAGE AND DURING IMPLANTATION". NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301438 ↗
• InjuryJan 8, 2021Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 13 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.;

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11140058 ↗
• InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 2 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE DUE TO MODERATE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8892803 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING OF THE SAME MODEL. ULTIMATELY THE 28MM RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC BIOPROSTHETIC MITRAL VALVE. THE PATIENT'S VALVE REQUIRED REPLACEMENT INSTEAD OF REPAIR DUE TO RESIDUAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8729519 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 30MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE REASON FOR EXPLANT WAS REPORTED AS MODERATE TO SEVERE RESIDUAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8727766 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8704541 ↗
• InjuryMay 24, 2019Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM RING OF THE SAME MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8640994 ↗
• InjuryMar 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8452956 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT BOTH THIS 30MM MITRAL ANNULOPLASTY BAND AND 30MM MITRAL ANNULOPLASTY RING WERE ATTEMPTED TO BE IMPLANTED, BUT ULTIMATELY WERE REPLACED WITH A NON-MEDTRONIC DEVICE DURING THE SAME PROCEDURE. THE REASON(S) FOR NOT USING THE BAND AND RING WERE NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8327398 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY BAND. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8305450 ↗
• InjuryNov 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 1 YEAR 11-MONTHS POST-IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8086219 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY SEVEN YEARS FOLLOWING THE IMPLANT OF THIS MITRAL ANNULOPLASTY RING, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-RING. THE INDICATION FOR PROCEDURE WAS SIGNIFICANT INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Insufficiency

  MAUDE report 8014966 ↗
• InjuryOct 26, 2018Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH BIOPROSTHETIC VALVE.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fibrosis; Mitral Valve Stenosis; No Information

  MAUDE report 8009477 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS 33 MM MITRAL RING, IT WAS SUBSEQUENTLY EXPLANTED. THE REASON FOR EXPLANT WAS DUE TO RESIDUAL MODERATE REGURGITATION. THE RING WAS REPLACED WITH A 29 MM BIOPROSTHETIC MITRAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7799078 ↗
• InjuryAug 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 30MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 32MM RING DUE TO A SIZING ERROR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7798574 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AT THE TIME OF SUTURE, THE PATIENT'S NATIVE VALVE WAS TORN DUE TO CALCIFICATION AND WAS NOT ABLE TO BE REPAIRED WITH THE 30MM ANNULOPLASTY RING. SUBSEQUENTLY, THE 30MM RING WAS EXPLANTED AND REPLACED WITH A LARGER RING OF THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Cusp Tear; No Information

  MAUDE report 7772822 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, SYSTOLIC ANTERIOR MOTION (SAM) WAS SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AFTER COMING OFF BYPASS. THEREFORE, THE RING WAS EXPLANTED AND REPLACED WITH A 34MM ANNULOPLASTY RING OF THE SAME MODEL. THE PHYSICIAN REPORTED THE DEVICE WAS NOT AT FAULT FOR THE SAM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7768241 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THIS 30MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR AS IT FAILED TO REPAIR THE PATIENTS NATIVE VALVE. AS A RESULT THE RING WAS REMOVED AND A 27MM MITRAL BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531633 ↗
• InjuryApr 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE DUE TO A "POOR FIT". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Known Impact Or Consequence To Patient

  MAUDE report 7442995 ↗
• InjuryFeb 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE PHYSICIAN REPORTED NOTHING WAS WRONG WITH THE RING BUT THE REPAIR WAS NOT SUFFICIENT SO REPLACEMENT WAS NEEDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7235504 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 30 MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE AND REPLACED WITH A 29 MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7046032 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS MITRAL ANNULOPLASTY RING. THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC TISSUE VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7041281 ↗
• InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE AS THE RING DID NOT CORRECT THE ISSUE. THERE WERE NO ALLEGATIONS AGAINST THE RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6999886 ↗